Tequin removed from market

Bristol-Meyers Squibb removing Tequin from market; antibiotic linked to serious blood-sugar complications as Public Citizen demands official recall

05/01/06

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Bristol-Meyers Squibb Co. confirmed on May 1, 2006 that it will stop manufacturing and selling the antibiotic Tequin, approved for sale in the U.S. in 1999 as an antibiotic. Bristol had acquired the rights to manufacture and sell the drug in the U.S. from Japanese drug maker Kyorin Pharmaceutical Company. The drug has faced growing criticism in the U.S. due to its link with high and low blood sugar in some patients.

Tequin, known generically as gatifolxacin, is an antibiotic prescribed for respiratory ailments, primarily chronic bronchitis, sinusitis, and pneumonia, although it is also prescribed for urinary tract infections (UTIs) and other serious infections. Tequin had an estimated $100 million in U.S. sales in 2005.

In February 2006, the U. S. FDA required Bristol to add new warnings to Tequin’s label, saying Tequin should not be used by diabetics, the elderly, or any people with kidney disease, as hypoglycemia and hyperglycemia could be life-threatening to those at-risk patients. The consumer group Public Citizen issued a petition to the FDA demanding an official recall of Tequin, saying there have been 388 patients who have reported blood-sugar irregularities while taking Tequin. Public Citizen claims that 159 of those patients required hospitalization, and 20 patients later died.

While Bristol is stopping production of the drug, Public Citizen fears more consumers could be in danger as remaining supplies are sold off instead of recalled.

Sources: Randolph E. Schmid, “Drug Company Taking Tequin off the Market,” Associated Press, May 1, 2006, accessed May 2, 2006; “U.S. group seeks ban on discontinued Bristol drug,” Reuters, May 1, 2006, accessed May 2, 2006.

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